Boston Scientific Corporation: Medical Device Recall in 2014 - (Recall #: Z-0724-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

Product Classification:

Class II

Date Initiated: November 20, 2013

Date Posted: January 22, 2014

Recall Number: Z-0724-2014

Event ID: 66907

Reason for Recall:

Sterility of device may be compromised due to lack of pouch seal integrity

Status: Terminated

Product Quantity: 3,300 eaches

Code Information:

Lot Numbers: H13061102, H13061104, H13062401, H13062402, H13071302, H13082603

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated